Programming manager, clinical programming

The Role Work arrangement: This role offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.

Responsibilities/tasks - including but not limited to: Implements and assists on developing company Study Data Tabulation Model (SDTM) standards that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, and analysis Ensures alignment of SDTM standards with data collection standards and relevant company tools/system requirements by reviewing study e CRFs, supporting creation of external data collection standards, and providing SDTM mapping guidance Ensures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity Creates quality control processes, metrics and other measures to ensure compliance with standards Ensures work carried out in accordance with applicable SOP's and working practices, as well as global agency regulations/guidance's Supports developing and reviewing standard processes and templates. Working with Digital Solutions and IT, support the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers Supports development of Gen Sense Dashboards by providing guidance on data structure, organization and contents of the Genmab SDTM-databases to the Dashboard developers and programmers Produce other in-house checks of data consistencies Contributes to knowledge sharing, skill building and good collaboration with stakeholders and colleagues Contributes to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge Maintains up-to-date knowledge on relevant regulatory guidelines/requirements Maintains a good working relationship with stakeholders and colleagues Participates and represent clinical programming in teams and meetings Requirements: Bachelor's degree in Statistics, Computer Science, Life Sciences. Master's degree in Statistics, Computer Science, Life Sciences preferred Has experience working in a global context Proficient in both written and spoken English At least 3-5 years of experience within the pharmaceutical industry Has experience with the SAS software package As Programming Manager, Clinical Programming, it is expected that the employee: Acts as a role model Leads programming study team in an effective and professional manner Proactively engages in department activities Arranges lessons learned to share learnings Leads various initiatives within the department · Proactively contributes to support a global organization Acts as mentor for new employees or consultants Competences and skills: SAS programming Analytical and problem-solving skills Expert knowledge of the CDISC SDTM data model: the corresponding structures and organizations of the data. Contextual understanding of the data Writes efficient, easily maintained and well documented computer programs Is systematic and organized in writing and archiving computer programs Proactive and Accountable and Goal oriented Innovative Good team player Good at sharing knowledge Works independently, take responsibility and show initiative Good communication skills Good planning and coordinating skills Ability to flexibly work on multiple tasks without compromise of the quality of the work For US based candidates, the proposed salary band for this position is as follows: The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U. S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending